510(k) · Cleared
ClearedDR. Hays Bite Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inventive Resources, Inc. · MQC Mouthguard, Prescription
Cleared on Feb 22, 2002 as substantially equivalent to K882303 (Hays & Meade, Inc., 1989) and 2 other predicates after a 73-day review. Its family tree reaches back 1 generation to 1989. 33 later devices descend from it.
- Decided
- Feb 22, 2002
- Review
- 73 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K882303 (1989). 3 ancestors in all. 33 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- This deviceK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- Descendant · cites it directly · 20 of its ownK024261 Dental ProtectorDental Concepts, LLC · 2003
- Descendant · 2 generations on · 17 of its ownK073220 The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc. · 2007
- Descendant · 3 generations on · 10 of its ownK082723 GrindguardGrind Guard Technologies, LLC · 2009
- Descendant · 4 generations on · 9 of its ownK123161 Smartguard Night Guard, Smartguard Original, Smartguard Night Guard…Smartguard, Inc. · 2013
- Descendant · cites it directly · 7 of its ownK111066 Migra Tab, Quicksplint MigraineMigratherapy, LLC · 2011
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K024261Dental ProtectorDental Concepts, LLC · 2003 · cites it directly20descendants
- K073220The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc. · 2007 · 2 generations on17descendants
- K082723GrindguardGrind Guard Technologies, LLC · 2009 · 3 generations on10descendants
- K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc. · 2013 · 4 generations on9descendants
- K111066Migra Tab, Quicksplint MigraineMigratherapy, LLC · 2011 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| 0 (this device) | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| +1 | K024261 | Dental Protector | Dental Concepts, LLC | 2003 | — |
| +2 | K073220 | The Doctor's Nightguard Advanced Comfort | Prestige Brands, Inc. | 2007 | — |
| +3 | K082723 | Grindguard | Grind Guard Technologies, LLC | 2009 | — |
| +4 | K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original… | Smartguard, Inc. | 2013 | — |
| +1 | K111066 | Migra Tab, Quicksplint Migraine | Migratherapy, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQC device
- #1 K203000 KeyPrint KeySplint Hardscore 15.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K882303 | H&M Anti-Snoring DeviceSummary page 1…ustom fit and trim each device to the patient. Materials: the Dr. Hays Bite Guard is made of Lexan and Elvax, the same materials as the Snore Guard device, cleared under K882303. ' The device is supplied Non-Sterile. The device is packaged in "clean only" condition but is free of manufacturing debris and/… | 1989 |
| * | K980953 | Accu-Bite Home Kit DiscluderSummary page 2…. Comparison to Predicate Device(s): Dr. Hays Bite Guard may be directly contrasted with the following equivalent devices: o SnoreGuard ™K882303. o Best Bite Decluder ™ K980953 e NTI Clenching Suppression System K981546 Summary Basis for Equivalence and Comparison Table: Based on the available informat… | 1998 |
| * | K981546 | Nti Clenching Suppression SystemSummary page 2…s Bite Guard may be directly contrasted with the following equivalent devices: o SnoreGuard ™K882303. o Best Bite Decluder ™ K980953 e NTI Clenching Suppression System K981546 Summary Basis for Equivalence and Comparison Table: Based on the available information concerning the referenced comparison dev… | 1998 |
What descends from it? (33)
See all 335 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQC
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQC
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQC
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQC
7in 2025
MAUDE reports naming product code MQC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 79 | 0 | 9 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 4 | 194 | 0 | 2 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 3 | 234 | 0 | 5 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 2 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 71 |
| 2019 | 5 | 286 | 0 | 62 |
| 2020 | 4 | 204 | 0 | 46 |
| 2021 | 7 | 158 | 0 | 111 |
| 2022 | 5 | 120 | 0 | 137 |
| 2023 | 6 | 230 | 1 | 62 |
| 2024 | 8 | 249 | 0 | 8 |
| 2025 | 4 | 185 | 0 | 7 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Protecting against tecth grinding, bruxism and jaw clenching.
Short-term pain relief from muscle spasm pain due to occlusal interference.
For the prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary teeth by the temporalis muscle. The device is custom made for the individual.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014079: DR. Hays Bite Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014079
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026